Dermatitis, AtopicPhase 4NCT02732314
Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
A Phase 4 study testing Investigational OTC Cream, Cosmetic Eczema Cream and 0.05% Desonide Cream in people with Dermatitis, Atopic and Eczema, run by Procter & Gamble Beauty at 1 site in United States.
Trial summary
This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Dermatitis, Atopic, Eczema
- What is being tested?
- Investigational OTC Cream, Cosmetic Eczema Cream and 0.05% Desonide Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is a generally healthy, male or female, 12-65 years old, inclusive
- Diagnosis of moderate or greater Atopic Dermatitis as determined by the Physician's Global Assessment (PGA of 3 or 4)
Who cannot join
- Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks
- Currently or has been diagnosed or treated for cancer in the past 5 years.
- Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- Has a known hypersensitivity to any corticosteroid creams.
- Has a known sensitivity to Epinephrine, Xylocaine or topical antibiotics.
- Has a wound healing or blood-clotting abnormality.
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- Has any active infections or has used antibiotics in the past 7 days.
- Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne)
- Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
- Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
- Is an employee of the Sponsor Company or clinical testing site.
- Is diabetic.
- Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
- Is currently pregnant or lactating or planning to become pregnant in the next 6 months.
- Has a history of keloid formation following skin injury.
- Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin, heparin, etc.)
- Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
About this study
This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc).
SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.
- Conditions
- Dermatitis, Atopic, Eczema
- Being tested
- Investigational OTC Cream, Cosmetic Eczema Cream, 0.05% Desonide Cream, Placebo Cream
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational OTC CreamDrug
Cosmetic Eczema CreamOther
Also called CeraVe
0.05% Desonide CreamDrug
Also called Actavis
Placebo CreamOther
| Study group | Role | What they receive |
|---|---|---|
| Investigational OTC Cream | Experimental | Investigational OTC Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. Receives: Drug: Investigational OTC Cream |
| Placebo Cream | Placebo comparator | Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. Receives: Other: Placebo Cream |
| Cosmetic Eczema Cream | Active comparator | Cosmetic Eczema Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. Receives: Other: Cosmetic Eczema Cream |
| 0.05% Desonide Cream | Active comparator | Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 4 weeks to atopic dermatitis lesions and then on any new lesions that appear for 4 weeks and as directed by the study doctor.
Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, anywhere the patient would apply their ordinary body moisturizer except atopic dermatitis lesions. Receives: Drug: 0.05% Desonide Cream; Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Measured: Change from Baseline at Week 12
Secondary outcomes (3)
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Measured: Change from Baseline at Week 2
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Measured: Change from Baseline at Week 4
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Measured: Change from Baseline at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter & Gamble Beauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Nasir, MD, PhD, Principal investigator, Wake Research Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732314
- Sponsor's protocol ID
- CSD2016003
- Status last verified
- Oct 2016
- First submitted
- 4 Apr 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02732314
- Acronym / sponsor ID
- CSD2016003
- Conditions
- Dermatitis, Atopic, Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Procter & Gamble BeautyIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc).
SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Investigational OTC Cream | Experimental | Drug: Investigational OTC CreamInvestigational OTC Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. |
| Placebo Cream | Placebo comparator | Other: Placebo CreamPlacebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. |
| Cosmetic Eczema Cream | Active comparator | Other: Cosmetic Eczema CreamCosmetic Eczema Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer. |
| 0.05% Desonide Cream | Active comparator | Drug: 0.05% Desonide Cream, Other: Placebo CreamRx Steroid applied topically, twice daily, once in the morning and once in the evening, for 4 weeks to atopic dermatitis lesions and then on any new lesions that appear for 4 weeks and as directed by the study doctor. Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, anywhere the patient would apply their ordinary body moisturizer except atopic dermatitis lesions. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Is a generally healthy, male or female, 12-65 years old, inclusive
- Diagnosis of moderate or greater Atopic Dermatitis as determined by the Physician's Global Assessment (PGA of 3 or 4)
Key exclusion criteria (17 listed)
- Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks
- Currently or has been diagnosed or treated for cancer in the past 5 years.
- Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- Has a known hypersensitivity to any corticosteroid creams.
- Has a known sensitivity to Epinephrine, Xylocaine or topical antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational OTC Cream | Drug | Investigational OTC Cream |
| Cosmetic Eczema CreamAlso: CeraVe | Other | Cosmetic Eczema Cream |
| 0.05% Desonide CreamAlso: Actavis | Drug | 0.05% Desonide Cream |
| Placebo Cream | Other | 0.05% Desonide Cream, Placebo Cream |
Primary outcome
SCORAD (Severity Scoring of Atopic Dermatitis)
Time frame: Change from Baseline at Week 12
Dermatologic assessment and scoring of atopic dermatitis lesion severity
3 secondary outcomes
SCORAD (Severity Scoring of Atopic Dermatitis)
Time frame: Change from Baseline at Week 2
SCORAD (Severity Scoring of Atopic Dermatitis)
Time frame: Change from Baseline at Week 4
SCORAD (Severity Scoring of Atopic Dermatitis)
Time frame: Change from Baseline at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Nasir, MD, PhD principal investigator
Wake Research Associates, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Investigational OTC Cream, Cosmetic Eczema Cream and 0.05% Desonide Cream in people with Dermatitis, Atopic and Eczema, run by Procter & Gamble Beauty at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD (Severity Scoring of Atopic Dermatitis) (time frame: Change from Baseline at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.